USER’S GUIDE FOR THE PRACTITIONER

COMPOSITION

A glass bottle containing: cellulose derivative product dissolved in ethyl alcohol to form a gel to which a contrast agent (tungsten) has been added

PRESENTATION

DISCOGEL® comes in the form of a kit ready kit for the use with the following characteristics: • One type I glass bottle containing 2.2 ml of solution for injection composed of a mixture ethyl alcohol, cellulose derivative product and tungsten, • Two 1 ml syringe, • One high-flow 19G5 needle, • Two 18G spinal injection needles, • One descriptive notice

CAUTION

All the essential elements of kit are in single use. The risk of reusing one of the elements can notably draw away septic risks, evaporation of active principle, problems of “seryngability” and a defect of effectiveness of the device

PROPERTY

The 96% pure ethyl alcohol produces a local necrosis of the nucleus pulposus. Its action is mechanical via a dehydration of the turgescent and protruding disc, which is compressing the peripheral nerves of the rachis, and causing extreme pain

DISCOGEL® is a sterile viscous solution containing ethyl alcohol, cellulose derivative product and tungsten: radio-opaque element. The injection of DISCOGEL® into the disc treats herniated discs and relieves lumbago, radicular or lumboradicular

DISCOGEL® is available in the form of a kit containing 2.2 ml of solution for injection with two disposable 1ml syringes (each for single use) and 2 needles which make administration straightforward, assure sterility and prevent contamination during use. The quantity of gel in one kit (a single bottle) permits filling the two 1 ml syringes provided

INDICATIONS

Treatment of herniated discs at any level of spine

CONTRAINDICATIONS

DISCOGEL® is not indicated for patients known to be allergic to one of the components, patients in severe depression or any other condition making the interpretation of pain difficult

DISCOGEL® is not indicated for pregnant woman

INSTRUCTIONS AND DOSAGE

The medical act corresponds to an injection into the disc (the intervertebral space) under radiological control. Injection is accomplished strictly into the herniated intervertebral disc whether it is lumbar, cervical or thoracic. The resuspension of the metallic contrast agent must be homogeneous at the time of its injection

Kit allows intervention on two discs (one needle and one syringe per disc). The quantity of DISCOGEL® injected per disc varies between 0.2 and 0.8 ml, according to the dimension of the disc and extent of the hernia

A syringe of 1 ml is provided so that any of these injection volumes is possible. In general, it is recommended to use: • 0.2 ml of DISCOGEL® for cervical discs • 0.3 ml – 0.5 ml of DISCOGEL® for thoracic discs • 0.6 ml – 0.8 ml of DISCOGEL® for lumbar and lumbar sacrum discs

PRECAUTIONS TO BE TAKEN DURING ADMINISTRATION

Injection Act takes place in an operating room equipped for radiology and surgery under aseptic conditions. It is recommended that DISCOGEL® be injected at room temperature (see chapter “Precautions to observe”). DISCOGEL® is directly injected into the spinal disc

The treatment is ambulatory. – Intervention The injection into the disc is accomplished, after asepsis and local anesthesia via the post lateral route for lumbar and thoracic discs and via the anterolateral route for cervical discs

Preferably the disc is punctured using a small needle of: • 20 Gauge for cervical disc (not provided in kit) • 18 Gauge for thoracic and lumbar discs (provided in kit), so as to reach the central region of the intra spinal space. – Nucleolysis (injection of ethyl alcohol gel) In absence of contraindication for nucleolysis, an injection herniated disc of ethyl alcohol gel is accomplished into the nucleus pulposus

At the beginning of the injection the patient may experience a transitional scalding sensation in the region of injection which disappears in the course of injection. To minimize this risk, the product must be injected very slowly

Once the product has been injected, the needle is left 2 minutes before being withdrawn. OTHERS The act must be performed by a medical professional of health familiar with percutaneous punctures of herniated discs

PRECAUTIONS TO OBSERVE The viscosity of DISCOGEL® depends on the temperature. Avoid an administration of the product warmed up above room temperature, because gel becomes more liquid and is below optimum viscosity

To increase its viscosity DISCOGEL® can be refrigerated just prior to injection. Administration to children: as the security of this product has not been established for children, extreme caution must be used especially in judging dose. REMARK The herniated disc is most often linked to a defect of muscle tone and posture

So, it is necessary to follow the treatment with postural re-education. A correctly designed program should avoid both relapse and hernia of other spinal discs

RECOMMENDATIONS

Simultaneous general or local complementary treatments can be used in case of facettaire pain. Additional, complementary intradiscal therapeutics are also possible in case of treatment of hernias with narrow canal, foraminal, extremely painful and “sleepless” hernias

SIDE EFFECTS

Although DISCOGEL® is a viscous product and opaque to x-ray allowing the administering physician to assure that it is confined within the disc, the theoretical possibility of escape into the periradicular or peridural zone during injection remains. The device based on ethanol could then draw away a feeling of transitional burn in the contact of a root. The violent and important high loss of the disc treated well that unlikely can lead to severe lumbagoes

INCOMPATIBILITY

DISCOGEL® should not be blended with other solutions

CONSERVATION

Keep in a temperature between +2°C and +25°C, protected from light. If this temperature cannot be assured, keep in a refrigerator at 4°C. COLLECTION AND ELIMINATON OF USED CONSUMABLES

Consumables after use must be discarded according to the rules of good practice

0 ردود

اترك رداً

Want to join the discussion?
Feel free to contribute!

اترك تعليقاً

لن يتم نشر عنوان بريدك الإلكتروني. الحقول الإلزامية مشار إليها بـ *